A study to evaluate the safety and tolerability of BMS-986408 alone and in combination with Nivolumab or Nivolumab and Ipilimumab in participants with advanced solid tumors
Summary description of the study
The primary objective of this study is to characterize the safety profile of BMS-986408 as monotherapy and in combination with Nivolumab or Nivolumab and Ipilimumab, to determine the maximum tolerated dose (MTD). Additionally, the recommended phase 2 dose (RP2D) will be determined, optimizing the pharmacokinetic/pharmacodynamic (PK/PD) ratio of BMS-986408.
(BASEC)
Intervention under investigation
Experimental: Part 1: BMS-986408 Monotherapy: Drug: BMS-986408 ➔ Fixed dose on fixed days
Experimental: Part 2: BMS-986408 in combination with Nivolumab: Drug: BMS-986408 ➔ Fixed dose on fixed days Biological: Nivolumab ➔ Fixed dose on fixed days Other names: - Opdivo - BMS-936558
Experimental: Part 2: BMS-986408 in combination with Nivolumab and Ipilimumab Drug: BMS-986408 Fixed dose on fixed days Biological: Nivolumab Fixed dose on fixed days Other names: Opdivo BMS-936558 Biological: Ipilimumab Fixed dose on specific days Other names: - Yervoy - BMS-734016
(BASEC)
Disease under investigation
Advanced solid tumors
(BASEC)
Inclusion criteria: • Participants with a histologically or cytologically confirmed, advanced, inoperable/metastatic solid malignant tumor of any histology that is measurable by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 • Participants who have received an existing therapy known to provide clinical benefit for the participant's disease, have been refractory to it, are not eligible for it, or cannot tolerate it • Participants with melanoma must demonstrate mutation status for the B-Raf proto-oncogene (BRAF) and the neuroblastoma RAS viral oncogene homolog (NRAS) • Participants must have experienced radiologically documented disease progression at or after the last therapy. (BASEC)
Exclusion criteria
Exclusion criteria: • An active, known or suspected autoimmune disease • Conditions requiring systemic treatment with corticosteroids within 14 days or other immunosuppressive medications within 30 days prior to the first dose of study treatment • Current or recently occurring gastrointestinal diseases or gastrointestinal surgeries that could affect the absorption of the study drug • Untreated metastases of the central nervous system (CNS) or leptomeningeal metastases Other inclusion/exclusion criteria as specified in the protocol. (BASEC)
Trial sites
Basel, Geneva, St. Gallen
(BASEC)
Sponsor
Sponsor: Celgene Corporation Princeton, NJ, USA Sponsor`s representative: Dr. Carmen Lilla Bristol Myers Squibb SA, Steinhausen, Switzerland
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr. Markus Jörger
+41 71 494 11 11
markus.joerger@clutterkssg.chCantonal Hospital St.Gallen, Rorschacherstrasse 95, st.Gallen, Sankt Gallen, Switzerland, 9007
(BASEC)
General Information
Bristol-Myers Squibb
(ICTRP)
Scientific Information
Bristol-Myers Squibb
(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethikkommission Ostschweiz EKOS
(BASEC)
Date of authorisation
10.05.2023
(BASEC)
ICTRP Trial ID
NCT05407675 (ICTRP)
Official title (approved by ethics committee)
CA099-003: Eine Phase-1/2-Studie zu BMS-986408 allein und in Kombination mit Nivolumab oder mit Nivolumab und Ipilimumab bei Teil-nehmern mit fortgeschrittenen soliden Tumoren (BASEC)
Academic title
A Phase 1/2 Study of BMS-986408 Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors (ICTRP)
Public title
A Study to Evaluate the Safety and Tolerability of BMS-986408 Alone and in Combination With Nivolumab or Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors (ICTRP)
Disease under investigation
Advanced Solid Tumors (ICTRP)
Intervention under investigation
Drug: BMS-986408;Biological: Nivolumab;Biological: Ipilimumab;Biological: Platinum-doublet chemotherapy;Drug: Rabeprazole (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- Participants with a histologically or cytologically confirmed, advanced,
unresectable/metastatic, solid malignancy of any histology measurable by Response
Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Participants who have received, been refractory to, ineligible for, or intolerant of
existing therapy(ies) known to provide clinical benefit for the condition of the
participant
- Participants with melanoma should have documentation of mutation status for B-type
Raf proto-oncogene (BRAF) and neuroblastoma ras viral oncogene homolog (NRAS)
- Participants must have experienced radiographically documented progressive disease
on or after the most recent therapy
Exclusion Criteria:
- An active, known or suspected autoimmune disease
- Conditions requiring systemic treatment with either corticosteroids within 14 days
or other immunosuppressive medications within 30 days of the first dose of study
treatment
- Current or recent gastrointestinal disease or gastrointestinal surgery that could
impact the absorption of study drug
- Untreated central nervous system (CNS) metastases or leptomeningeal metastasis
Other protocol-defined inclusion/exclusion criteria apply (ICTRP)
not available
Primary and secondary end points
Number of participants with Dose-Limiting Toxicities (DLTs);Number of participants with Adverse Events (AEs);Number of deaths (ICTRP)
Maximum concentration (Cmax);Time of maximum observed concentration (Tmax);Area under the concentration-time curve from time 0 to time of last quantifiable concentration (AUC (0-T));Objective Response Rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;Duration of Response (DOR) assessed by RECIST v1.1 (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Bristol-Myers Squibb, Bristol-Myers Squibb (ICTRP)
Secondary trial IDs
CA099-003 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT05407675 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available